Captopril

Product NDC: 0904-5046
11-digit product format: 009045046
Labeler code: 0904
Product ID: 0904-5046_d3c13f78-6f86-4d72-a5bf-5229d65fc4ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Captopril
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA074505
Marketing category: ANDA
Marketing start: 1996-02-13
Marketing end: 2022-07-31
Substance: CAPTOPRIL
Active strength: 25 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0904-5046		D	Discontinued by firm		2026-08-07
excluded package	package	0904-5046	0904-5046-61	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0904-5046-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0904-5046-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0904-5046-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0904-5046-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0904-5046-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0904-5046-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0904-5046-61	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0904-5046-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0904-5046-61	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0904-5046-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0904-5046-61	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0904-5046-61	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074505-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13
A074505-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13
A074505-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13
A074505-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074505-001	AB
A074505-002	AB
A074505-003	AB
A074505-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074505-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074505-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-5046-61	EA - Each	0904-5046	706452d9-97e4-4f98-b7f5-291559efb24e	1	2012-07-24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Captopril	CAPTOPRIL	Golden State Medical Supply, Inc.	d117c8bd-50a8-7355-e053-2a95a90ac70f	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505
Captopril	CAPTOPRIL	PD-Rx Pharmaceuticals, Inc.	65ed6e70-f1ee-437e-965c-d1b1fdadd832	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505
Captopril	CAPTOPRIL	Hikma Pharmaceuticals USA Inc.	607687f4-63cf-411c-a20b-21d238a6b7a7	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505
Captopril	CAPTOPRIL	American Health Packaging	9b54feb0-13cd-46a8-9924-f12880381196	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9G64RSX1XD	CAPTOPRIL	62571-86-2	CAPTOPRIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-5046-61	00904504661	100 BLISTER PACK in 1 CARTON (0904-5046-61) > 1 TABLET in 1 BLISTER PACK	100 blister pack	1996-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CAPTOPRIL TABLETS, USP Rev. 11/19 Rx Only	Major Pharmaceuticals	2021-09-13	HUMAN PRESCRIPTION DRUG LABEL	13